Efficacy of Patient Controlled Epidural Anesthesia Versus Continuous Epidural Analgesia for Post-thoracotomy Pain

Phase 4

Completed

• Conditions: Acute Post-thoracotomy Pain

• Registration Number: NCT01560429
• Lead Sponsor: Queen's University

Brief Summary

Postoperative thoracotomy pain is normally managed with an epidural catheter and continuous epidural analgesia (CEA). However, for some surgical procedures, patient controlled epidural anesthesia (PCEA) is more effective but little research has compared the two methods following thoracotomy. The current randomized, prospective clinical investigation did just this. Following institutional ethics approval 52 patients scheduled for thoracotomy were recruited for this prospective, randomized, unblinded study. A thoracic epidural catheter was sited preoperatively. Postoperatively all patients were titrated on continuous epidural infusions (hydromorphone 10 mcg/mL + bupivacaine 1 mg/mL) until pain scores were stable at ≤3 on a numeric rating scale (NRS). Then they were allocated to their preoperatively determined randomization (either remained on continuous epidural infusion or they were switched to receive 2/3 of the stabilized background dose via continuous epidural infusion with the option to self-administer the remaining 1/3rd of the dose via PCEA. Participants remained on their allocated analgesic regimens for 48 hours postoperatively. The primary outcome was consumption of local anaesthetics/opioids. The secondary outcomes were worst pain and pain while coughing (0-10 NRS).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Results First Submitted: 2013-06-12
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Results First Posted: 2016-07-21
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 18-75 years of age
• American Society of Anesthesiologist's (ASA) Physical Status I-III
• Body Mass Index (BMI) < 40
• Able to use a PCEA device

Exclusion Criteria

• Intolerance/hypersensitivity to agents used in the study
• Contraindication to epidural placement
• Current alcohol/substance abuse
• Chronic pain condition requiring chronic analgesic
• BMI ≥ 40 or body weight less than 50kg.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anesthetic Consumption (mg)	4,8,12, 24 and 48 hours postoperatively	amount of anesthetic consumed was calculated for each group over time.
Local Anesthetic Consumption	48 hours postoperatively	Amount of anesthetic consumed (either through epidural catheter or as rescue bolus at 48 hours following thoracotomy administered either through CEA or PCEA.

Secondary Outcome Measures

Name	Time	Method
Worst Pain While Coughing	48 hours postoperatively	Worst pain on a numerical rating scale(0-10 worst) at 24 and 48 hours following thoracotomy
Worst Pain Scores	48 hours postoperatively	worst pain scores on numerical rating scale (0-10, where 10 is the worst) at 24 \& 48 hours following surgery

Trial Locations

Locations (1)

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada